Financial Support in an Underserved and Low-Income Population With Heart Failure

Quality of Life Clinical Trial

— FUND-HF  

Official title:

Financial Support in an Underserved and Low-Income Population With Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928026
• Other study ID #: STU-2022-1033
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Ambarish Pandey, MD, MSCS
• Phone: 214-645-9762
• Email: ambarish.pandey[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test whether financial support in the form of a one-time $500 stipend would improve medication adherence and quality of life in low-income, socially-needy patients with heart failure with reduced ejection fraction in the post-discharge setting. The main questions it aims to answer are:

• Will financial support improve heart failure quality of life?

• Will financial support improve medication adherence?

Participants will complete surveys on quality of life, social stress, and spending habits at their baseline visit. Participants will be randomly assigned to receive $500 at their baseline visit or $0 at their baseline visit. At their one month visit, quality of life and medication adherence will be assessed. These results will be compared between groups. The group that received $0 at their baseline visit will be provided $500 at their one-month visit and return for a two-month visit. At that visit, quality of life and medication adherence will be assessed. These results will be compared to their one-month results.

Researchers will compare the 1-month quality of life scores and medication adherence scores between the immediate financial support vs delayed financial support. Researchers will also compare 1-month vs 2-month quality of life and adherence data for participants who were randomized to the delayed financial support group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age > 18

• English speaking participants who completed SOCIAL-HF study surveys

• Ejection Fraction <=40% and eligible for at least one component of GDMT

• Has at least some difficulty paying monthly bills (Somewhat Difficult and Very Difficult)

• Annual household income <130% Federal Poverty Limit

• Have at least two additional social needs based on the following domains:

• Cost-related nonadherence

• Food Insecurity

• Housing Instability

• Transportation Difficulty

• Unemployment

• Household Crowding: Person/Room Ratio >1

• Rent Burden: Rent/Income Ratio >30%

• Low social support

• Interpersonal Violence

• History of Discrimination

Exclusion Criteria:

• Unwilling to return for 1 and 2-month follow-up visits.

• Currently in jail or prison

• Primary residence outside Dallas County

• Legal Blindness

• Systolic blood pressure <90 mmHg on screening

• Contraindications or Intolerance all medications available for therapeutic drug monitoring (metoprolol, losartan, lisinopril, valsartan, and spironolactone)

• Unable to answer orientation questions.

Related Conditions & MeSH terms

• Financial Stress
• Heart Failure
• Heart Failure, Systolic
• Medication Adherence
• Quality of Life

Intervention

Behavioral:
• Financial Support
A debit card will be loaded with $500 and can be used like a typical debit card.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

Akwo EA, Kabagambe EK, Harrell FE Jr, Blot WJ, Bachmann JM, Wang TJ, Gupta DK, Lipworth L. Neighborhood Deprivation Predicts Heart Failure Risk in a Low-Income Population of Blacks and Whites in the Southeastern United States. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e004052. doi: 10.1161/CIRCOUTCOMES.117.004052. — View Citation

Barankay I, Reese PP, Putt ME, Russell LB, Loewenstein G, Pagnotti D, Yan J, Zhu J, McGilloway R, Brennan T, Finnerty D, Hoffer K, Chadha S, Volpp KG. Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019429. doi: 10.1001/jamanetworkopen.2020.19429. — View Citation

Greene SJ, Butler J, Albert NM, DeVore AD, Sharma PP, Duffy CI, Hill CL, McCague K, Mi X, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Fonarow GC. Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry. J Am Coll Cardiol. 2018 Jul 24;72(4):351-366. doi: 10.1016/j.jacc.2018.04.070. — View Citation

Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24. — View Citation

Henderson KH, Helmkamp LJ, Steiner JF, Havranek EP, Vupputuri SX, Hanratty R, Blair IV, Maertens JA, Dickinson M, Daugherty SL. Relationship Between Social Vulnerability Indicators and Trial Participant Attrition: Findings From the HYVALUE Trial. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e007709. doi: 10.1161/CIRCOUTCOMES.120.007709. Epub 2022 Apr 14. — View Citation

Hood SR, Giazzon AJ, Seamon G, Lane KA, Wang J, Eckert GJ, Tu W, Murray MD. Association Between Medication Adherence and the Outcomes of Heart Failure. Pharmacotherapy. 2018 May;38(5):539-545. doi: 10.1002/phar.2107. Epub 2018 Apr 30. — View Citation

Liao L, Allen LA, Whellan DJ. Economic burden of heart failure in the elderly. Pharmacoeconomics. 2008;26(6):447-62. doi: 10.2165/00019053-200826060-00001. — View Citation

Riegel B, Lee CS, Ratcliffe SJ, De Geest S, Potashnik S, Patey M, Sayers SL, Goldberg LR, Weintraub WS. Predictors of objectively measured medication nonadherence in adults with heart failure. Circ Heart Fail. 2012 Jul 1;5(4):430-6. doi: 10.1161/CIRCHEARTFAILURE.111.965152. Epub 2012 May 30. — View Citation

Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272. — View Citation

Volpp KG, Troxel AB, Mehta SJ, Norton L, Zhu J, Lim R, Wang W, Marcus N, Terwiesch C, Caldarella K, Levin T, Relish M, Negin N, Smith-McLallen A, Snyder R, Spettell CM, Drachman B, Kolansky D, Asch DA. Effect of Electronic Reminders, Financial Incentives, and Social Support on Outcomes After Myocardial Infarction: The HeartStrong Randomized Clinical Trial. JAMA Intern Med. 2017 Aug 1;177(8):1093-1101. doi: 10.1001/jamainternmed.2017.2449. — View Citation

Wu JR, Frazier SK, Rayens MK, Lennie TA, Chung ML, Moser DK. Medication adherence, social support, and event-free survival in patients with heart failure. Health Psychol. 2013 Jun;32(6):637-46. doi: 10.1037/a0028527. Epub 2012 Jul 2. — View Citation

Wu JR, Holmes GM, DeWalt DA, Macabasco-O'Connell A, Bibbins-Domingo K, Ruo B, Baker DW, Schillinger D, Weinberger M, Broucksou KA, Erman B, Jones CD, Cene CW, Pignone M. Low literacy is associated with increased risk of hospitalization and death among individuals with heart failure. J Gen Intern Med. 2013 Sep;28(9):1174-80. doi: 10.1007/s11606-013-2394-4. Epub 2013 Mar 12. — View Citation

Wu JR, Moser DK, De Jong MJ, Rayens MK, Chung ML, Riegel B, Lennie TA. Defining an evidence-based cutpoint for medication adherence in heart failure. Am Heart J. 2009 Feb;157(2):285-91. doi: 10.1016/j.ahj.2008.10.001. Epub 2008 Dec 24. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychologic Stress by Kessler Screening Scale	This is a ten-item instrument measuring psychological distress. Each item has a five-level response scale. The range is 10-50, with higher scores denoting greater psychological distress.	1 Month
Other	Psychologic Stress by Kessler Screening Scale	This is a ten-item instrument measuring psychological distress. Each item has a five-level response scale. The range is 10-50, with higher scores denoting greater psychological distress.	2 months
Other	Number of Emergency Room Visits	This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium	1 Month
Other	Number of Emergency Room Visits	This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium	2 Month
Other	Number of Hospitalizations	This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium	1 Month
Other	Number of Hospitalizations	This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium	2 months
Other	Appointment Completion Rate	This outcome will be captured through review of the electronic medical records	1 Month
Other	Appointment Completion Rate	This outcome will be captured through review of the electronic medical records	2 months
Primary	Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)	Quality of life will be ascertained using the KCCQ-12, a validated measure of quality of life among patients with heart failure. The score contains four domains, physical limitation, symptom frequency, quality of life, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 denoting the best possible health. These scores are averaged and presented as a summary score.	1 month
Primary	Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)	Quality of life will be ascertained using the KCCQ-12, a validated measure of quality of life among patients with heart failure. The score contains four domains, physical limitation, symptom frequency, quality of life, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 denoting the best possible health. These scores are averaged and presented as a summary score.	2 months
Secondary	Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)	This will be ascertained using serum therapeutic drug monitoring of guideline-directed medical therapies.	1 month
Secondary	Self-reported medication adherence by Morisky Medication Adherence Scale	Self-reported medication adherence will be captured by the Morisky Medication Adherence Scale. This scale is an eight-item survey. The score ranges from 0-8, with higher scores denoting greater adherence.	1 month
Secondary	Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)	This will be ascertained using serum therapeutic drug monitoring of guideline directed medical therapies.	2 months
Secondary	Self-reported medication adherence by Morisky Medication Adherence Scale	Self-reported medication adherence will be captured by the Morisky Medication Adherence Scale. This scale is an eight-item survey. The score ranges from 0-8, with higher scores denoting greater adherence.	2 months
Secondary	Change in social stress	This will be captured using the perceived stress scale. This is a ten-item survey assessing perceived stress over the last month. The scores range from 0-40, with higher scores denoting higher perceived stress.	1 months
Secondary	Change in social stress	This will be captured using the perceived stress scale. This is a ten-item survey assessing perceived stress over the last month. The scores range from 0-40, with higher scores denoting higher perceived stress.	2 months